Device Listing 1391907267

Listing Summary#

Listing key
1391907267
Premarket submission
K153140
Device
Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating
Applicant
Terumo Cardiovascular Systems Corp.
Product code
DTZ
Decision date
2015-12-02